Light Exposure, Migraine Outcomes, and Sleep Quality
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorArizona State University
About this trial
The purpose of this study is to examine the relationship between daily light exposure patterns, sleep quality, and migraine characteristics in adults with migraine, with and without photophobia, across an 8-week study period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Meet the International Classification of Headache Disorders, 3rd edition (2018) criteria for migraine, with or without aura or photosensitivity
Report experiencing more than 4 headache days per month and at least three migraine attacks per month
No other major health issues based on self-reported data
Able to read and communicate in English
Disqualifiers
Light therapy
Use light-altering devices (e.g., blue-blocking contact lenses or glasses)
Traveling out of town during the participation
Trial design
Design model
Single group
Treatments tested in this trial
Ambient Lighting Condition
Other interventionApplication of an optimized ambient lighting condition through placement of a dimmable LED floor lamp in participants' private workspaces to create a standardized workplace lighting environment during working hours. The floor lamp emits white light with a specified spectral distribution and intensity. Participants may adjust brightness for comfort. The lighting system is used solely to modify the ambient workplace lighting environment during the 4-week intervention period.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Optimized Lighting InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Monthly Migraine Days
Number of migraine days per 28-day period as recorded in daily electronic headache diaries. A migraine day is defined as a calendar day with a self-reported migraine meeting International Classification of Headache Disorders (ICHD-3) criteria. The primary analysis will compare the 4-week baseline period to the 4-week intervention period within participants.
Time frame
Baseline (Weeks 1-4) compared to Intervention (Weeks 5-8)Secondary outcomes
1
Change in Migraine Headache Intensity
Average migraine pain intensity recorded in daily electronic headache diaries using a numerical rating scale (e.g., 0-10). Mean intensity during the 4-week baseline period will be compared to the 4-week intervention period within participants.
Time frame
Baseline (Weeks 1-4) compared to Intervention (Weeks 5-8)2
Change in Migraine-Specific Quality of Life (MSQ v2.1) Score
Change in total and domain scores on the Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1). Higher scores indicate better quality of life. Scores at baseline will be compared to scores at Week 8.
Time frame
Baseline (Week 0), Between Baseline and Intervention (end of Week 4), and End of Intervention (Week 8).3
Change in Objective Sleep Efficiency
Sleep efficiency measured by wrist-worn actigraphy, defined as the percentage of time in bed spent asleep. Average sleep efficiency during the 4-week baseline period will be compared to the 4-week intervention period.
Time frame
Baseline (Weeks 1-4) compared to Intervention (Weeks 5-8)4
Change in Average Daily Ambient Light Intensity
Average daily ambient light intensity (lux) measured using a wearable light sensor. Daily mean illuminance (lux) will be calculated for each participant and averaged across the 4-week baseline period and the 4-week intervention period. The primary comparison is baseline versus intervention within participants.
Time frame
Baseline (Weeks 1-4) compared to Intervention (Weeks 5-8)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Arizona State University
Lead sponsor
Flinn Foundation
Collaborator
Source ClinicalTrials.gov